Wearable infusion device and system

ABSTRACT

Disclosed is a drug infusion system comprising a drug infusion device having a reservoir, a window for viewing the contents of the reservoir, a cannula arranged to be deployed beneath the skin of a patient, and an actuator configured to be manually actuated to drive a medicament from the reservoir to the cannula. The system also has a cannula cover and a needle handle that holds a needle for insertion into the patient. The cannula cover and needle handle are detachably attached to the drug infusion device, and each is attachable to the other. The device further comprises a septum and a septum pincher to seal the device. The device also comprises a pumping mechanism, part of which are a last-dose lock-out mechanism and an occlusion detection mechanism, both of which operate on the same actuator.

FIELD OF THE INVENTION

The present invention relates to infusion devices and more particularlyto such devices that enable liquid medicaments to be conveniently andsafely self-administered by a patient.

BACKGROUND OF THE INVENTION

Administration of insulin has traditionally been accomplished using asyringe. Recently, needle carrying pen-like devices have also beenemployed for this purpose. Both forms of insulin administration requirethe patients to stick themselves each time they inject insulin, oftenmany times a day. Thus, these traditional forms of insulinadministration have been a rather pervasive intrusion in the lives androutines of the patients who have had to adopt and employ them.

More recently, insulin pumps attached by tubing to an infusion setmounted on the patient's skin have been developed as an alternative formof insulin administration. Such pumps may be controlled by aprogrammable remote electronic system employing short range radiocommunication between a control device and electronics that control thepump. While such devices may involve fewer needle sticks, they areexpensive to manufacture. They are also complex to operate andcumbersome and awkward to wear. Further, the cost of such devices can bemany times the daily expense of using a traditional injection means suchas a syringe or an insulin pen.

Devices of the type mentioned above also require a significant amount oftraining to control and thus use. Great care in programming the devicesis required because the pumps generally carry sufficient insulin to lasta few days. Improper programming or general operation of the pumps canresult in delivery of an excessive amount of insulin which can be verydangerous and even fatal.

Many patients are also reluctant to wear a pump device because they canbe socially awkward. The devices are generally quite noticeable and canbe as large as a pager. Adding to their awkwardness is their attachmentto the outside of the patient's clothes and the need for a catheter liketubing set running from the device to an infusion set located on thepatient's body. Besides being obvious and perhaps embarrassing, wearingsuch a device can also be a serious impediment to many activities suchas swimming, bathing, athletic activities, and many activities such assun bathing where portions of the patient's body are necessarilyuncovered.

In view of the above, a more cost effective and simple device has beenproposed whereby an injection system is discreetly attached directly tothe skin of the patient. The device may be attached to the patient underthe patient's clothing to deliver insulin into the patient by the manualpumping of small doses of insulin out the distal end of a temporarilyin-dwelling cannula that is made a part of the pump device. The cannulamay be made a part of the drug delivery device before, during or afterthe attachment of the drug delivery device to the skin of the patient.The device may be made quite small and, when worn under the clothes,entirely unnoticeable in most social situations. It may still carrysufficient insulin to provide the patient the necessary dose for severaldays. It can be colored to blend naturally with the patient's skin colorso as not to be noticeable when the patient's skin is exposed. As aresult, insulin for several days may be carried by the patientdiscreetly, and conveniently applied in small dosages after only asingle needle stick. For a more complete description of devices of thistype, reference is made to co-pending application Ser. No. 11/906,130,filed on Sep. 28, 2007 with the title DISPOSABLE INFUSION DEVICE WITHDUAL VALVE SYSTEM, which application is owned by the assignee of thisapplication and hereby incorporated herein by reference in its entirety.

The present invention provides further improvement to the devicesdisclosed in the above referenced co-pending application. Moreparticularly, the devices disclosed herein provide for improved patientsafety and/or convenience. For example, embodiments of the inventiondescribed here provide, improved sealing of the medicament, moreconvenient cannula deployment, device misuse prevention, easier primingmethods, and fluid path occlusion detection. These and other advantagesare addressed herein.

SUMMARY OF THE INVENTION

According to one embodiment, a drug infusion system comprises askin-adherable drug infusion device comprising a reservoir, a cannulaarranged to be deployed beneath the skin of a patient, and an actuatorconfigured to be manually actuated to drive a medicament from thereservoir to the cannula. The system further comprises a cannula coverand a needle handle. The needle handle holds a needle for insertion intothe patient.

The cannula cover may be configured to be detachably attached to thedrug infusion device. The needle handle may be configured to bedetachably attached to the drug infusion device.

The needle handle may be configured to be coupled to the cannula cover.The cannula cover may include a cavity for receiving the needle when theneedle handle is coupled to the cannula cover.

The device preferably includes an adhesive layer for adhering to theskin of a user and a removable cover overlying the adhesive layer. Thecannula cover may be attached to the removable cover on the adhesivelayer so that as the cannula cover is removed from the device, theremovable cover is also removed with it.

The device may comprise a last-dose lock-out mechanism and/or anocclusion detection mechanism. Both the last-dose lock-out mechanism andthe occlusion detection mechanism may be configured to operate on thesame actuator.

The system may further comprise an inserter for inserting the needleinto the skin of a patient. The device may include a fill port throughwhich the reservoir receives medicament. The cannula cover may include aguide port that guides a medicament supply instrument into alignmentwith the fill port. The guide port may include a stop structure thatlimits penetration of the medicament supply instrument within the fillport. The cannula cover may include a priming window through whichpriming of the device may be observed. The device may include a windowfor viewing the contents of the reservoir.

According to another embodiment, a drug infusion device comprises askin-adherable surface, a reservoir for holding a medicament, a cannulaarranged to be deployed beneath the skin of a patient that delivers themedicament to the patient, an actuator to drive a medicament from thereservoir to the cannula, an insertion needle port that receives aninsertion needle and which fluidly communicates with the cannula, aseptum configured to seal the insertion needle port, and a septumpincher configured to press against the septum to assist the septum insealing the insertion needle port.

According to a further embodiment, a drug infusion system comprises askin-adherable drug infusion device comprising a reservoir, a cannulaarranged to be deployed beneath the skin of a patient, and an actuatorconfigured to be manually actuated to drive a medicament from thereservoir to the cannula. The system further comprises a cannula coverarranged to be releasably joined with the device to protect the cannulaand is arranged to capture medicament during priming of the device.

The channel may include a plurality of inwardly radially projecting finsfor capturing the medicament during priming of the device. The fins arepreferably longitudinally extending within the channel. The cannulacover may include a priming window through which priming of the devicemay be observed within the channel.

According to a still further embodiment, a drug infusion devicecomprises a skin-adherable surface, a reservoir for holding amedicament, a cannula arranged to be deployed beneath the skin of apatient that delivers the medicament to the patient, and an actuator todrive a medicament from the reservoir to the cannula. The cannulaincludes a tip end output port and at least one side output port. Thecannula may include a pair of side output ports. The side output portsmay be directly opposite each other.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further features and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify identical elements, and wherein:

FIG. 1 a is a top perspective view of a drug infusion system accordingto an embodiment of the present invention;

FIG. 2 is an exploded view in perspective of the infusion system of FIG.2;

FIG. 3 is a view of the bottom of the drug infusion system of FIG. 1;

FIG. 4 is an exploded view in perspective of the drug infusion system ofFIG. 3;

FIG. 5 is a perspective view illustrating a manner of the device of thedrug infusion system of FIG. 1 according to an embodiment of theinvention;

FIG. 6 is a view, similar to FIG. 4, illustrating the removal of acannula cover of the drug infusion system of FIG. 1 according to thisembodiment;

FIG. 7 is a side perspective view, illustrating the device of the druginfusion system of FIG. 1 after deployment on a user's skin;

FIG. 8 is a side perspective view, illustrating the device of the druginfusion system of FIG. 1 after deployment on a user's skin and duringremoval of a needle and needle handle according to this embodiment;

FIG. 9 is a side perspective view illustrating the safe storage of theneedle in the cannula cover according to this embodiment;

FIG. 10 is a perspective view of the device of the system of FIG. 1 witha top cover removed to illustrate the internal components of the deviceaccording to an embodiment of the invention;

FIG. 11 is a partial perspective view illustrating the last-doselock-out and occlusion detection mechanisms of the device according toan embodiment of the present invention;

FIG. 12 is a sectional view of the device of the system of FIG. 1illustrating internal components of the device according to thisembodiment;

FIG. 13 is a perspective view to an enlarged scale showing of the top ofthe device with the cover removed to illustrate further details of thedevice according to this embodiment;

FIG. 14 is an exploded perspective view of the device illustratingselected ones of the internal components of the device;

FIG. 15 is a partial, sectional side view of the device of the system ofFIG. 1 to an enlarged scale illustrating an actuator of the deviceaccording to this embodiment;

FIG. 16 is a perspective view of another device having sealed actuatorsin accordance with a further embodiment;

FIG. 17 is a top view of the device of FIG. 16 with portions removed toillustrate details of the actuator of the device;

FIG. 18 is a perspective of a drug infusion device including a filter inaccordance with an embodiment that may be employed to advantage ineither the device of FIG. 1 or FIG. 16;

FIG. 19 is an exploded perspective view of a drug infusion deviceembodying the invention together with an inserter for deploying thedevice in accordance with further aspects of the invention;

FIG. 20 is a perspective view of the device being placed into theinserter to ready deployment of the device;

FIG. 21 is a perspective view of the device within the inserter;

FIG. 22 is a perspective view of the device within the inserter andafter the cannula cover has been removed;

FIG. 23 is a side view of the inserter placed against a user's skin justprior to deployment of the device within the inserter;

FIG. 24 is an exploded plan view illustrating the device deployed on auser's skin with the inserter separated from the device;

FIG. 25 is a perspective view illustrating the cannula cover beingreplaced over the inserter needle and needle handle; and

FIG. 26 is an exploded perspective view illustrating the inserter needlecover removed from the inserter and joined into the cannula cover forsafely storing the inserter needle and permitting inserter reuse.

FIG. 27, it is a top perspective view of the cannula cover to illustratefurther details in accordance with one embodiment of the presentinvention;

FIG. 28, it is a bottom perspective view of the cannula cover of FIG.27;

FIG. 29 is a perspective side view, to an enlarged scale and withportions cut away, of a cannula and an insertion needle according to anembodiment of the present invention; and

FIG. 30 is a partial sectional side view in perspective showing thesyringe in the filling position within the device according to anembodiment of the invention.

DETAILED DESCRIPTION

The present invention is generally directed to infusion devices as, forexample, where each manual actuation of the device by a patientadministers a preset dose of a medicament (such as insulin). Inexemplary embodiments, the device is filled with a predetermined volumeof insulin and then worn on the skin for a period of time (e.g., up tothree days). Whenever a dose of medicament is desired, the device ismanually actuated (or activated) to provide a dose of medicament to thepatient.

FIGS. 1 and 2 show an infusion system 100 embodying the presentinvention. The system 100 comprises an infusion device 110, a needlehandle 120 which carries an insertion needle and a syringe guide andcannula cover 130 (hereinafter referred to as a cannula cover) whichcovers a cannula 180 (180 doesn't show up until FIG. 4) that protrudesfrom the device. The device 110 further comprises an adhesive layer 140on the underside of the device and actuators 150 and 160 on either sideof the device. As shown in FIG. 2, the outer shell of device 110 has aneedle opening 111 to receive a needle 170 which is held by the needlehandle 120. The outer shell of device 110 also has notches 112 toreceive corresponding latching feet 125 of the needle handle 120. Thefeet 125 and notches 112 permit the needle handle to be releasablyjoined to the device 110.

As shown in FIG. 3, adhesive layer 140, viewing window 113, and cannulacover 130 are located on the underside of device 110. Adhesive layer 140is configured to be attached to the patient's skin and comprises a cover(not shown) that is removable for adhering to a patient's skin. Althoughthe viewing window 113 is shown as being located on the underside of thedevice, it may alternatively be located on the top of the device. Thewindow 113 is a clear portion that enables a user to look into thedevice and into the contents of a reservoir held within the device. Itis used to visually determine the fill-level of the reservoir, tovisually assist in the removal of air bubbles before cannula deployment,and optionally to notice any irregularities of the medicament within thereservoir.

The cannula cover 130 comprises an opening 131 that is configured toreceive a syringe and syringe needle. Optionally, opening 131 is coveredby a cover (not shown) that may be opened or removed. As will besubsequently shown in further detail, a syringe filled with medicamentis inserted into opening 131. Opening 131 ultimately communicates withthe reservoir within the device through a port within the device and aseptum. This permits medicament to be introduced into the reservoir ofdevice 110 for filling.

The cannula cover 130 serves a dual function. It facilitates guidedcoupling of the syringe to the device and provides a protective coverfor the cannula. This is seen in FIG. 4. FIG. 4 shows the underside ofthe device that lies beneath the elevated cannula cover 130. Port 114 isin line with opening 131. This permits the syringe that enters throughopening 131 to ultimately enter port 114.

FIG. 5 illustrates the filling of the device 110. Syringe S is insertedinto the port 131 of the cannula cover 130, as shown. The syringe S isused to fill the reservoir of the device with a desired quantity of themedicament. The filling of the reservoir may be observed through theviewing window 113.

Once the reservoir is filled, the cannula cover 130 is removed from thedevice as shown in FIG. 2 b to expose the cannula 180. Protruding fromthe cannula 180 is the insertion needle 170. The other end of the needle170 which is attached to the needle handle 120 on the opposite side ofthe device.

Prior to the placement of the device on the skin, and either prior tothe removal of the syringe guide, or even just after it, the device isprimed for use. Priming occurs through activating the actuator buttonsto advance the fluid within the device. Fluid is directed at leastpartly towards the mouth of cannula 180, with the needle 170 withincannula 180.

The adhesive layer 140 is also prepared for adhesion to the skin, forexample by removing a cover that overlies the adhesive. To this end, andin accordance with one embodiment of the invention, the cannula cover130 may be attached to the cover overlying the adhesive layer of thedevice, such that when the cannula cover 130 is removed, the cover isalso removed. The device thus prepared is then driven into the skin, asshown in FIG. 7, either by a patient pressing the device onto the skinsuch that the cannula 180 and the insertion needle 170 pierce the skin,or through the aid of an inserter, such as that described below and asdisclosed in co-pending U.S. application Ser. No. 12/543,352, which isincorporated herein by reference. The inserter may be configured toreceive device 100, or a portion thereof. Upon actuation by the patient,the inserter would drive the cannula and insertion needle into the skinof the patient.

Once the device is deployed on the skin, the needle handle 120 isdetached from the rest of the device. This is shown in FIG. 8. Needle170 is attached to the needle handle 120 and thus is also removed withthe handle 120 from the device 110. Cannula 180 remains attached to thedevice 110 and thus remains within the tissue of the patient. To safelydispose of the insertion needle 170, needle handle 120 may be attachedto cannula cover 130 as shown in FIG. 9. As shown here, the needle 170is received by an elongated cavity 136 of the cannula cover 130.

Turning now to the internal components of the device 110, FIG. 10 showsthe inside of device 110 from a top perspective view, with the top cover110 removed. The device 100 comprises a reservoir 115, a needle holecover 121, a needle septum 122, a septum pincher 123, actuator buttons151 and 161, actuation springs 152 and 162, a base plate 141, anintroducer septum 116 (which underlies port 114 in FIG. 4), pumpmechanism 181, a valve stem 184, a locking mechanism 187 and a cannulaport 185.

The reservoir 115 comprises a hollow base overlayed with one or morelayers of flexible, bio-compatible film. The film is a laminate film ofsufficient thickness and flexibility to hold a medicament. The film maybe in the form of a fillable bag or pouch that is overlaid on the base,or it may be in the form of a flexible cover for the base, with themedicament directly introduced between the film and the base.

The reservoir is in communication with the introducer septum 116.Introducer septum 116 underlies port 114 (FIG. 4), and thus is the entrypoint for the medicament that is introduced by the syringe. Port 114 isthus in fluid communication with reservoir 115, such that medicamententering through port 114 and septum 116 is ultimately transported intoreservoir 115 for storage and later delivery to cannula port 185.

In accordance with this embodiment, actuation occurs by concurrentmanual depression of the actuator buttons 151 and 161. Such actuationcauses the medicament to flow through the pump mechanism 181 and valvestem 184 and ultimately through the cannula and into the patient.

The pump mechanism within the device is similar to that described inco-pending applications US20090088690, PCT/US2009/048922, and U.S.application Ser. No. 12/543,352. The pump mechanism is configured to beacted upon by the actuator buttons, such that when a user manuallyactuates the actuators, the forward actuation stroke propels medicamentfrom the pump mechanism into the cannula. The return actuation strokethen pulls medicament from the reservoir into the pump mechanism fordelivery upon the next actuation. Among other features, the pumpmechanism optionally comprises a last-dose lock-out mechanism 182,similar to what was described in co-pending application US20090088690.Briefly, this last-dose lock-out mechanism 182 (shown in FIG. 11)mechanically detects the absence of medicament flowing from thereservoir to the pump mechanism. When such absence of flow occurs, themechanism engages a portion of the locking mechanism 187. Lockingmechanism 187 is connected to actuator button 151, and when engaged bythe last dose lock-out mechanism 182, prevents actuator button 151 frombeing actuated.

The pump mechanism also optionally comprises an occlusion detectionmechanism 183, similar to that described in co-pending applicationPCT/US2009/048922. Briefly, the occlusion detection mechanism (alsoshown in FIG. 11) mechanically detects an occlusion (e.g., crystallizedmedicament), within the medicament stream flowing through the pumpmechanism 181. Once an occlusion is detected, the mechanism engages aportion of locking mechanism 187. This in turn engages a portion ofactuator button 151, preventing actuator button 151 from being actuated.It should be noted that in accordance with the present invention, boththe occlusion detection mechanism 183 and the last-dose lockoutmechanism 182 of the device are configured to operate upon the sameactuation button, providing added manufacturing efficiency and attendantcost benefits.

The device also comprises several novel safety features. One of thesefeatures is the closable needle septum, shown in FIG. 12. As previouslymentioned, the needle 170 is placed through the device to extend throughand out the cannula on the other side. After serving the purpose duringdevice deployment of piercing the skin, the needle is withdrawn. Inorder to maintain the sterility and integrity of the internal fluidpathway of the device, a needle septum 122 is located on the inside ofthe device, just inside the top cover of device 110. Needle septum 122is configured to be a self sealing septum and thus prevents any furthermaterials from entering the device after the needle has been withdrawn.However, in some situations, after the needle is withdrawn from septum122, it may leave a hole within septum 122. In order to close the hole,and prevent seepage of medicament into the rest of the device, a septumpincher 123 is provided and configured to press the septum closed duringactuation. As can be seen in FIG. 12, which is a sectional view of thedevice and FIG. 13 which is a perspective view of the device, pincher123 is slidable within a cavity 124 within the device. Pincher 123, asshown in this embodiment, has a non-uniform cross-section along allaxis. However, other configurations of a pincher may be utilized.Pincher 123 is configured to be acted upon by portion 165 of actuator161. Actuator 161 being depressed causes the pincher 123 to slide alongcavity 124 and to contact and press against septum 122. This pressing ofseptum 122 causes it to collapse around the opening left by the needle.In one embodiment, after actuation, when the actuator button 161 returnsto its normal position, the pincher 123 also slides back to its originalposition within cavity 124. Alternatively, as seen in FIG. 13, thepincher may be configured to permanently press against the septum upon afirst actuation. To this end, pincher 123 is provided with a latchingportion 125 that corresponds to a latch-receiving portion 126 in thewall of cavity 124. In this configuration, once the actuator 161 isdepressed, and the pincher 123 slides forward in cavity 124, latchingportion 125 slides into receiving portion 126.

Another safety feature is a cover for the needle hole 111. The explodedview of FIG. 14, the needle hole 111 within the top cover 113 overliesneedle septum 122, which in turn overlies cannula port 185. Thus, theentry of any fluid or extraneous matter through needle hole 111 may gothrough cannula port 185, into cannula 180, and ultimately into thepatient. This is particularly dangerous if a patient mistakenly tries torefill the reservoir of the device by inserting a syringe into theneedle hole 111 and depositing a large volume of medicament therein. Toprevent this scenario, a needle hole cover 121 is provided. Needle holecover 121 is located among the internal components of the device. It isaffixed to the underside of the top cover 113 of the device, and aportion of 121′ covers needle septum 122. In its initial state, when theneedle is pierced through the septum (not shown), the portion 121′ isdisplaced to one side. After the needle has been removed, the portion121′ moves to cover the septum and prevent a user from accidentally orintentionally injecting any substance (including any more medicament)directly into the cannula.

Another safety feature is the prevention of extraneous materials (e.g.,water, dust particles) from entering the interior of the device past theactuator elements of the device. One such provision is shown in FIG. 15.This figure exemplarily shows a detailed view of actuator 150, but itmust be understood that actuator 160 may comprise similar structure andfeatures. The actuator 150 comprises an actuator button 151 and at leastone spring 152. Overlying the actuator button 151 and spring 152 is anactuator cover 153. Actuator cover overlies both button 151 and spring152 in a manner as to prevent the entry of extraneous material into thespring components and the internal mechanisms of the device 110.Actuator cover 153 is made of a compressible substance and comprises afurrow 154. Furrow 154 comprises an undulatable fold that allows thebutton to be depressed and retracted while maintaining the seal that thecover 153 provides to the outside of the device.

Another configuration of the actuators is shown in FIGS. 16 and 17. Inthis embodiment, the actuator buttons 151′ and 161′, are overlain bycasings 174 and 175 respectively. At the center of the casings, areactuator depressor buttons 176 and 177. As seen in FIG. 17, depressorbuttons 176 and 177 are in mechanical communication with actuatorbuttons 151′ and 161′ respectively. When depressor button 176 isdepressed, it contacts and consequently depresses actuator button 151′.Similarly, when depressor button 177 is depressed, it contacts andconsequently depresses actuator button 161′. The device is thus actuatedupon depression of the depressor buttons. A seal 178 may be providedaround the depressor buttons, between the button and the casing, tofurther protect the integrity of the internal components of the deviceand prevent extraneous materials from entering into the device. The sealis in the form of an o-ring but may be any suitable seal.

Another feature can be provided in the form of a filter that capturesany microbes or particles in the fluid stream between the reservoir andthe cannula. One such filter embodying the invention is shown in FIG.18, where filter 191 is placed within the fluid stream between thereservoir and the cannula. The filter 191 is placed in the streambetween the occlusion detection mechanism 182 and the cannula. However,it may be placed anywhere along the fluid path where it is suitable. Forexample, if the downstream placed filter is found to interfere with thefunctioning of the occlusion detection mechanism 183, the filter may beplaced upstream from the occlusion detection mechanism 183.

As previously noted, the embodiments of the drug delivery device may beused in conjunction with an inserter configured to insert the needle 170into the skin. FIG. 19 is an exploded view of the infusion device 110and an inserter 200 for deploying the device in accordance with furtheraspects of the present invention. The inserter 200 includes a housing202 dimensioned to receive the device 110. The device 110 may thus beplaced into the inserter 200 in the direction of the arrow. The inserterhousing 202 includes a moveable top 204 that has an inner surfacecontour that matches the general surface contour of the device 110. Thetop 204 has an opening 206 for receiving the insertion needle handle 120that protrudes from the device 110. The inserter housing 202 has a sidewall 208 that includes guide channels 210. The guide channels 210slidingly receive guide extensions 212 that extend from the inserter top204. The guide channels 210 and guide extensions 212 serve tocontrollably guide the translation of the top 204, and hence the device110, during deployment of the device 110. To that end, the top may bemanually driven by the user or the top may be driven by a mechanicaldrive force as may be provided by the stored energy of a drive spring(not shown) within the inserter housing 202, for example.

As the infusion device 110 is being loaded into the inserter 200, thedevice 110 is pushed down into the movable top 204 of the inserter 200.As it is being pushed, the movable top 204 slides down along guidechannels 210. The pushing of the movable top also compresses a spring(not shown) held under the movable top 204. At the end of the guidechannels, a locking mechanism (not shown) locks the movable top in itsdepressed state. FIG. 20 shows the device 110 fully loaded into theinserter 200.

Now, the cannula cover 130 may be removed from the device 110. FIG. 21shows a removable cover 141 that covered the adhesive layer 140 (FIG. 1)being removed along with the cannula cover 130. To that end, the cannulacover 130 may be releasably adhered to the cover 141 to permit the cover141 to be removed with the cannula cover 130 but also later separatedthere from. The device 110 is now ready for deployment. If the removablecover 141 is not attached to the cannula cover 130, it is removed fromthe device 110 at this time and the device 110 will now be ready fordeployment with the inserter 200.

FIG. 22 shows the device 110 and the inserter 200 after the cannulacover and removable cover have been removed. This leaves the cannula 180and the insertion needle exposed to penetrate the user's skin and theadhesive layer 140 ready for attaching the device 110 to the user'sskin. FIG. 23 shows that the inserter 200 has been placed against theskin 101 of the patient. Now, upon actuation of the inserter 200, eitherby manual force or released stored force from the internal spring, theentire device 100 will be driven to the skin of the patient. This willcause the cannula and insertion needle to penetrate the patient's skinand the adhesive surface of the base of the device to contact and beadhered to the patient's skin.

FIG. 24 shows the device 110 on the patient's skin 101 after theinserter 200 has been removed. The adhesive layer 140 of the device isadhered to the patient's skin. FIG. 24 also illustrates the inserter 200and the insertion needle 170 being pulled from the device 110 in thedirection of the arrow. The insertion needle 170 is attached to thehandle 120 (not shown), which is in turn received in opening 206 (seeFIG. 19). Thus, when inserter 200 is pulled upward from device 110,handle 120, and thus needle 170 are pulled also. Alternatively, theneedle handle 120 is arranged to separate from the opening 206 when theinserter 200 is pulled upward. Thereafter, the needle handle 120 may bemanually pulled from the device 110 by the user.

As shown in FIG. 25, the cannula cover 130 may now be placed over theneedle handle 120. This serves to safely store the needle.

The needle is now safely stored within cannula cover 130. Further, asmay be seen in FIG. 26, the needle handle 120, and the cannula cover130, and the needle (not shown) safely stored therein may now be removedas a single unit from the inserter 200. This allows the inserter 200 tobe reused with another infusion device while still maintaining the safestorage of the insertion needle. Referring now to FIG. 27, it is a topperspective view of the cannula cover 130 to illustrate further detailsthereof. Here it may be seen that the opening 131 that receives thesyringe S (FIG. 5) defines a cylindrical channel that includes anannular shoulder 132 therein. As will be seen subsequently, the annularshoulder 132 forms a stop that limits the depth in which the needle ofthe syringe may penetrate the device. This prevents accidental damage tothe device during filling.

The cannula cover 130 also includes a priming window 134. The window 134is aligned with the cannula when the device is primed. This enablesactual viewing of the cannula tip end during priming. FIG. 27 also showsthe feet 125 that permit the cannula cover 130 to be releasably attachedto the body of the infusion device as previously described.

Referring now to FIG. 28, it is a bottom perspective view of the cannulacover 130. In addition to the opening 131, the cannula cover includesthe cavity 136 and a priming channel 138.

The cavity 136 is arranged to receive the inserter needle when thehandle, with inserter needle, are joined with the cannula cover afterthe device has been deployed as previously described. This again,provides for the safe storage of the inserter needle within the cavity136.

The priming channel 138 terminates with the priming window 134 (FIG.27). The channel 138 has a plurality of radially inwardly projecting andlongitudinally extending fins 139. As previously described, when thedevice is primed, the cannula is covered with the cannula cover 130 andthe cannula is carried on the insertion needle. Hence, the cannula andinsertion needle extend into the bore 138 during priming. The fins 139are arranged to be adjacent the distal end of the cannula.

FIG. 29 is a perspective side view, to an enlarged scale and withportions cut away, of a cannula 180 and insertion needle 170 accordingto further aspects of the present invention. Here it may be seen thatthe cannula 180 has aligned side ports 282 and 284. The side ports 282and 284 are directly opposite each other so as to project medicament inopposite directions. The inner channel 285 of the cannula is tapered atits distal end 286 and terminates in a central, tip end, output port289. The size of the output port 289 is such that it is nearly sealed bythe insertion needle 170 while, because of the taper in the innerchannel 285, an annular passage 287 to the side ports 282 and 284 isprovided. Hence, during priming of the device, the fluid is forced downthe annular passage 287. Nearly all of the fluid passing down thepassage 287 exits through the side ports 282 and 284. The fluid exitingthe side ports 282 and 284 may be viewed through the priming window 134(FIG. 27) to indicate the device is adequately primed for use.

The fins 139 are arranged to be adjacent the side ports 282 and 284during priming and present a large surface area to the fluid exiting theside ports. This results in a surface tension that captures the exitingfluid between the fins. Later, when the device is deployed and thecannula cover and insertion needle handle are joined, the fluid thatexited the device during priming will be captured therein. Thelongitudinal extent of the channel 138 and fins 139 enable cannulas andinsertion needles of different lengths to be accommodated. Also, thechannel 138 serves a dual purpose of protecting the cannula andinsertion needle prior to deployment and also facilitating priming ofthe device.

The side ports 282 and 284 also provide an additional function. Duringuse of the device, should the opening at the distal tip end of thecannula ever become clogged, the medicament will still be administeredto the patient through the side ports. Hence the side ports provide anauxiliary medicament delivery path for the device.

Referring now to FIG. 30, it is a partial sectional side view inperspective showing the syringe S in the filling position within thedevice 110. Here it may be seen that the filling syringe S includes anannular surface 134 that engages the annular shoulder 132 of the fillingchannel 131. By engaging the annular surface 134 of the syringe S, theannular shoulder 132 forms a stop structure that limits the depth ofpenetration of the syringe needle 135 within the fill port 114. Morespecifically, the tip end of the syringe needle 135 is permitted toextend just through the filling septum 133 to protect the device fromdamage. Hence, the cannula cover opening 131 not only serves to guidethe syringe S into the device for filling, but it also protects thedevice from damage by the needle.

While particular embodiments of the present invention have been shownand described, modifications may be made. It is therefore intended inthe appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention as defined bythose claims.

1. A drug infusion system comprising: a skin-adherable drug infusiondevice comprising a reservoir, a cannula arranged to be deployed beneaththe skin of a patient, and an actuator configured to be manuallyactuated to drive a medicament from the reservoir to the cannula; acannula cover; and a needle handle, wherein the needle handle holds aneedle for insertion into the patient.
 2. The system of claim 1, whereinthe cannula cover is configured to be detachably attached to the druginfusion device.
 3. The system of claim 1, wherein the needle handle isconfigured to be detachably attached to the drug infusion device.
 4. Thesystem of claim 1, wherein the needle handle is configured to be coupledto the cannula cover.
 5. The system of claim 4, wherein the cannulacover includes a cavity for receiving the needle when the needle handleis coupled to the cannula cover.
 6. The system of claim 1 wherein thedevice includes an adhesive layer for adhering to the skin of a user anda removable cover overlying the adhesive layer and wherein the cannulacover is attached to the removable cover on the adhesive layer.
 7. Thesystem of claim 1, wherein the device comprises a last-dose lock-outmechanism.
 8. The system of claim 1, wherein the device comprises anocclusion detection mechanism.
 9. The system of claim 8, wherein thedevice comprises a last-dose lock-out mechanism, and wherein both thelast-dose lock-out mechanism and the occlusion detection mechanism areconfigured to operate on the same actuator.
 10. The system of claim 1,wherein the system further comprises an inserter for inserting theneedle into the skin of a patient.
 11. The system of claim 1, whereinthe device includes a fill port through which the reservoir receivesmedicament, and wherein the cannula cover includes a guide port thatguides a medicament supply instrument into alignment with the fill port.12. The system of claim 11, wherein the guide port includes a stopstructure that limits penetration of the medicament supply instrumentwithin the fill port.
 13. The system of claim 1, wherein the cannulacover includes a priming window through which priming of the device maybe observed.
 14. The system of claim 1, wherein the device includes awindow for viewing the contents of the reservoir.
 15. A drug infusiondevice comprising: a skin-adherable surface; a reservoir for holding amedicament; a cannula arranged to be deployed beneath the skin of apatient that delivers the medicament to the patient; an actuator todrive a medicament from the reservoir to the cannula; an insertionneedle port that receives an insertion needle and which fluidlycommunicates with the cannula; a septum configured to seal the insertionneedle port; and a septum pincher configured to press against the septumto assist the septum in sealing the insertion needle port.
 16. Thedevice of claim 15, further comprising a last-dose lock-out mechanism.17. The device of claim 15, further comprising an occlusion detectionmechanism.
 18. The device of claim 15, further comprising a last-doselock-out mechanism, and wherein both the last-dose lock-out mechanismand the occlusion detection mechanism are configured to operate on thesame actuator.
 19. A drug infusion system comprising: a skin-adherabledrug infusion device comprising a reservoir, a cannula arranged to bedeployed beneath the skin of a patient, and an actuator configured to bemanually actuated to drive a medicament from the reservoir to thecannula; and a cannula cover arranged to be releasably joined with thedevice, the cannula cover including a channel for receiving the cannulaof the device when releasably joined with the device to protect thecannula and being arranged to capture medicament during priming of thedevice.
 20. The system of claim 19, wherein the channel includes aplurality of inwardly radially projecting fins for capturing themedicament during priming of the device.
 21. The system of claim 20,wherein the fins are longitudinally extending within the channel. 22.The system of claim 19, wherein the cannula cover includes a primingwindow through which priming of the device may be observed within thechannel.
 23. A drug infusion device comprising: a skin-adherablesurface; a reservoir for holding a medicament; a cannula arranged to bedeployed beneath the skin of a patient that delivers the medicament tothe patient; and an actuator to drive a medicament from the reservoir tothe cannula, wherein, the cannula includes a tip end output port and atleast one side output port.
 24. The device of claim 23, wherein thecannula includes a pair of side output ports.
 25. The device of claim24, wherein the side output ports are directly opposite each other.